A Study to Evaluate the Relative Bioavailability of Two Tablet Formulations Compared to Capsule Formulation and the Effect of Food and Proton Pump Inhibitor on ZN-A-1041 Tablet(s) in Healthy Participants
Launched by GENENTECH, INC. · Jun 26, 2025
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how two different tablet forms of a medication called ZN-A-1041 compare to the capsule form in terms of how the body absorbs them. The study also looks at how taking the tablet with food or with another medicine called rabeprazole (which reduces stomach acid) might affect the absorption of the tablet. The goal is to understand the best way to take this medicine for future use.
People who may be eligible to join this study are healthy adults between 18 and 74 years old with a body weight and health status within certain limits. Participants must have no serious health problems, no infections like hepatitis or HIV, and be able to follow specific instructions such as fasting before taking the medicine and eating a high-fat meal when required. Pregnant or breastfeeding women, people with certain heart conditions, or those taking other medications that affect how the body processes drugs cannot join. If you participate, you will be asked to take the medicine in different forms under controlled conditions, sometimes with food or the acid-reducing drug, so researchers can see how your body handles it. This study helps ensure the medicine is safe and effective before it is used more widely.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Body mass index (BMI) within the range of 18 to 32 kg/m\^2, inclusive
- • Negative hepatitis panel and negative HIV antibody screens
- • Negative screening test for latent Mycobacterium tuberculosis infection
- • Able to consume the high-fat meal within the protocol-specified time period and willing to consume 100% of the high-fat meal
- • Able to fast for 8 hours prior to dosing
- Exclusion Criteria:
- • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder
- • Personal or family history of congenital long QT syndrome
- • History of significant hypersensitivity, intolerance, or allergy to any drug
- • History of acute GI symptoms
- • History of ophthalmological disease or clinically significant abnormality in the ophthalmic examination
- • Have significantly impaired hepatic function
- • Female who is pregnant or breastfeeding or intending to become pregnant during the study or within 90 days following the final ZN-A-1041 administration
- • Have a QTc interval corrected through use of Fredericia's formula \>450 millisecond (msec), PR interval \>210 msec, QRS complex \>120 msec, or heart rate \<50 beats per minute (bpm)
- • Use of any drugs known to be moderate or strong inhibitors or inducers of CYP3A or CYP2C8
- • Poor peripheral venous access
- • History of malignancy within 5 years prior to enrollment
About Genentech, Inc.
Genentech, Inc. is a leading biotechnology company and a member of the Roche Group, dedicated to transforming the lives of patients with serious medical conditions through innovative therapies. Established in 1976, Genentech is recognized for its pioneering research in biologics and for developing groundbreaking treatments in areas such as oncology, immunology, and neuroscience. With a commitment to scientific excellence and patient-centered care, the company leverages cutting-edge technology and collaborative partnerships to advance drug discovery and development. Genentech's robust pipeline and focus on personalized medicine underscore its mission to address unmet medical needs and improve health outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Leeds, , United Kingdom
Patients applied
Trial Officials
Clinical Trials
Study Director
Genentech, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported